Implantable middle ear transducer having diagnostic detection sensor

ABSTRACT

Methods and devices for measuring vibration of an implanted driven vibrating elongate body coupled to a bone of the middle ear, for example using an accelerometer coupled to the vibrating body. The measured vibration can be taken during implantation and long again after implantation to check for possible decoupling, disease, or additionally impeded vibratory driving of the middle ear bone. An accelerometer signal can be converted to a displacement value and used to check for an under impeded or over impeded vibratory body. An implanted device can be used to periodically check the vibration of the vibratory body. Methods and devices can be used in conjunction with implanted devices which receive vibratory signals from a middle ear bone and use the signals to drive a disarticulated middle ear bone closer to the ear drum.

RELATED APPLICATIONS

The present application claims priority to and is a divisional of U.S.patent application Ser. No. 13/649,254, titled IMPLANTABLE MIDDLE EARTRANSDUCER HAVING DIAGNOSTIC DETECTION SENSOR, filed Oct. 11, 2012, nowU.S. Pat. No. 9,525,949, which is incorporated by reference in itsentirely.

TECHNICAL FIELD

The present invention is related generally to implantable medicaldevices. More specifically, the present invention is related toimplantable transducers, which can be used in partial middle earimplantable or total middle ear implantable hearing aid systems.

BACKGROUND

In an anatomically normal human hearing apparatus, sound waves, whichrepresent acoustical energy, are directed into an ear canal by the outerear (pinna) and impinge upon a tympanic membrane (eardrum) interposed atthe terminus of the ear canal between the ear canal and the middle earspace. The pressure of the sound waves effect tympanic vibrations in theeardrum, which then become manifested as mechanical energy. Themechanical energy in the form of tympanic vibrations is communicated tothe inner ear by a sequence of articulating bones located in the middleear space, to which are generally referred as the ossicular chain. Theossicular chain must be intact if acoustical energy existing at theeardrum is to be conducted as mechanical energy to the inner ear. Theossicular chain includes three primary components: the malleus, theincus, and the stapes. The malleus includes respective manubrium, neck,and head portions. The manubrium of the malleus attaches to the tympanicmembrane at a point known as the umbo. The head of the malleus, which isconnected to the manubrium by the neck portion, articulates with one endof the incus, which provides a transmission path for the mechanicalenergy of induced vibrations from the malleus to the stapes. The stapesincludes a capitulum portion connected to a footplate portion by meansof support crura and is disposed in and against a membrane-coveredopening to the inner ear, referred to as the oval window. The incusarticulates the capitulum of the stapes to complete the mechanicaltransmission path.

Normally, tympanic vibrations are mechanically conducted through themalleus, incus, and stapes, to the oval window and to the inner ear(cochlea). These mechanical vibrations generate fluidic motion(transmitted as hydraulic energy) within the cochlea. Pressuresgenerated in the cochlea by fluidic motion are accommodated by a secondmembrane-covered opening between the inner and middle ear, referred toas the round window. The cochlea translates the fluidic motion intoneural impulses corresponding to sound perception as interpreted by thebrain. However, various disorders of the tympanic membrane, ossicularchain and/or inner ear can occur to disrupt or impair normal hearing.

Hearing loss, which may be due to many different causes, is generally oftwo types, conductive and sensorineural. Of these types, conductivehearing loss occurs when the normal mechanical pathways for sound toreach the hair cells in the cochlea are impeded, for example, damage tothe ossicles or the ossicular chain. Conductive hearing loss may oftenbe helped by use of conventional hearing aids, which amplify sound sothat acoustic information does reach the cochlea and the hair cells. Inother cases, conductive hearing loss can be helped by the use of amiddle ear implant, which essentially augments or bypasses themechanical conduction of the ossicular chain. Some examples of such amiddle ear implant can be found in U.S. Pat. Nos. 4,729,366 and4,850,962 of Schaefer.

In some types of partial middle ear implantable (P-MEI) or total middleear implantable (T-MEI) hearing aid systems, sounds produce mechanicalvibrations within the ear which are converted by an electromechanicalinput transducer into electrical signals. These electrical signals arein turn amplified and applied to an electromechanical output transducer.The electromechanical output transducer causes an ossicular bone tovibrate in response to the applied amplified electrical signals, therebyimproving hearing.

An electromechanical output transducer used for the purpose of causingan ossicular bone to vibrate may be mounted in or near the middle ear.The transducer, also known as a driver, is generally contained in ahousing or enclosure, forming an assembly that facilitates the placementof the transducer within or near the middle ear.

In some previous designs, the output transducer assembly is coupled tosome part of the middle ear and has its output portion typically coupledto the moving part of the ear, e.g. the stapes or another element in theossicular chain. The output transducer, which may be piezoelectric,electromagnetic, electrostatic, or another mechanism, is mechanicallycoupled to the moving portion of the ear to be vibrated.

One method, for measuring the output vibration of the middle ear elementto which the output transducer is coupled, is called Laser DopplerVelocimetry (LDV) or Laser Doppler Vibrometry. LDV typically uses ahelium-neon laser, or something similar, and can be used to measure theDoppler shift between incident and reflected light from a vibratingsurface such as a middle ear element or a middle ear transducer. ThisDoppler shift measurement can be used to calculate velocity,displacement, or acceleration of a middle ear element or middle eartransducer. LDV equipment can be expensive, and making LDV measurementsin the middle ear can be difficult.

An elongate vibratory body, sometimes called a bimorph or bi-element,can be used to drive a bone in the middle ear. Often the bimorph willhave two piezoelectric layers or bodies disposed on either side of acentral conducting vane. When the top layer is caused to expand byapplication of an electric field, and the bottom layer is caused tocontract by application of an electric field, the elongate body orbimorph will bend. Long after the implantation procedure, methods suchas LDV obviously cannot be used due to the device residing within humantissue.

Undesirable changes may occur long after implantation. It istheoretically possible for the vibratory body to be decoupled from themiddle ear bone. The growth of scar tissue, tumors, or other growthcould impede the movement of the driven middle ear bone or other elementand/or the vibrating body. Fluid buildup could also impede thevibrations. For these and other reasons, measuring the vibration of thedriven middle ear bone and/or the vibratory body would also be desirablelong after the initial surgery.

SUMMARY

Some embodiments of the present invention provide a method for treatinga human, the method including: securing an accelerometer to a boneand/or tissue of the middle ear; and electronically and/or opticallycoupling the accelerometer to an implantable device disposed outside ofthe middle ear, where the accelerometer is secured to a vibrationaldevice or is part of the vibrational device. In some methods theimplantable device is implanted in a human skull. The securing is doneduring surgery in some such methods. One embodiment provides a methodfor sensing the vibrational driving of a middle ear bone by a vibratingelement coupled to the middle ear bone, the vibrating element having anaccelerometer coupled to the vibrating element and/or part of thevibrating element, the method including: coupling the vibrating elementto the middle ear bone; and measuring a signal indicative of theacceleration from the accelerometer at a first time after the coupling.In one method the coupling is performed during a surgery and the firsttime measuring is performed during the surgery. The first time signalmeasuring includes receiving an electrical signal electronically coupledto the accelerometer and/or receiving an optical signal opticallycoupled to the accelerometer, in various embodiments. The first timesignal measuring can include receiving an optical signal opticallycoupled to the accelerometer. The method can also include converting thesignal indicative of acceleration to a value indicative of velocity,and/or converting the signal indicative of acceleration to a valueindicative of displacement, in various embodiments. The first timemeasuring can be used to determine proper coupling of the vibratingelement to the middle ear bone. The first time measuring can beperformed after the surgery is complete and/or during surgery.

Some methods also include a second measuring of the signal indicative ofthe acceleration from the accelerometer at a second time after thecoupling, in which the second measuring time is at least one month afterthe coupling, and further comprising comparing the first and secondmeasuring time signals. The method can also include determining whetherthe vibrational driving is indicative of a vibrating element beinguncoupled from the middle ear bone and/or include determining whetherthe vibrational driving is indicative of excessively impeded vibrationof the middle ear bone.

The second measuring is compared to the first measuring to check fordecoupling of the vibrator from the middle ear bone and/or to check forimpeding of the vibration from the middle ear bone.

In various methods the accelerometer is a self-powered sensor, apiezoelectric device, an externally powered sensor, a capacitive deviceand/or combinations thereof.

Some embodiments of the present invention include a system for detectingvibration of a middle ear bone, the system including: an accelerometerelectronically and/or optically coupled to an implantable electronicdevice, the implantable electronic device having implemented methods forconverting accelerometer signals to displacement signals. In somesystems the method includes electronically implemented instructions forconverting the accelerometer signals to displacement signals. In varioussystems the accelerometer is a capacitive type sensor, the accelerometeris a piezoelectric type sensor, the accelerometer is electronicallycoupled to the implantable electronic device, the accelerometer isoptically coupled to the implantable electronic device, and/orcombinations thereof.

Embodiments of the present invention can include an implantablevibrational device for vibrating a bone of the middle ear, the deviceincluding: an elongate member having a first end region for securing tothe skull and a second end region for coupling to a middle ear bone; anaccelerometer secured to the elongate member second region; and a signalcommunication element for communicating information to a locationoutside of the elongate member where the signal communication element iscoupled to the accelerometer. The signal communication element caninclude an electrical wire and/or an optical signal conductor in whichthe wire and/or optical conductor can extend from the first end. Invarious devices the accelerometer is capacitive, piezoelectric,self-powered, or externally powered and combinations thereof.

Some embodiments of the invention include a method for detecting animplantable vibrator being decoupled from a bone of the middle ear, themethod including: measuring acceleration of the vibrator and using thatacceleration measurement to compare to a previously measured coupledvibrator accelerometer measurement and/or comparing that measurement toa model of a freely vibrating end.

One invention embodiment provides a method for detecting an implantablevibrator coupled to a bone of the middle ear having the vibrationundesirably impeded, the method including: measuring acceleration of thevibrator and using that acceleration measurement to compare to apreviously measured coupled vibrator accelerometer measurement.

DESCRIPTION OF DRAWINGS

FIG. 1 illustrates a frontal section of an anatomically normal humanright ear.

FIG. 2 is a cross-sectional illustration of a typical prior art use of abi-element transducer coupled to an auditory element in the middle ear.

FIG. 3 is a cross-sectional illustration of a prior art bi-elementtransducer secured only to a vibrated auditory element.

FIG. 4 is a cross-sectional illustration of a prior art bi-elementtransducer secured only to a vibrating auditory element.

FIG. 5 is a schematic drawing of a bi-element transducer having anaccelerometer included in the distal tip.

FIG. 6 is schematic drawing of a bi-element transducer having anaccelerometer included in the distal region.

DETAILED DESCRIPTION

The following detailed description should be read with reference to thedrawings, in which like elements in different drawings are numberedidentically unless otherwise indicated. The drawings depict selectedembodiments and are not intended to limit the scope of the invention. Itwill be understood that embodiments shown in the drawings and describedbelow are merely for illustrative purposes, and are not intended tolimit the scope of the invention as defined in the claims.

Some embodiments of the invention provide an electromechanicaltransducer which is particularly advantageous when used in a middle earimplantable hearing aid system, such as a partial middle ear implantable(P-MEI), total middle ear implantable (T-MEI), or other hearing aidsystem. A P-MEI or T-MEI hearing aid system assists the human auditorysystem in converting acoustic energy contained within sound waves intoelectrochemical signals delivered to the brain and interpreted as sound.

FIG. 1 illustrates, generally, the human auditory system. Sound wavesare directed into an external auditory canal 20 by an outer ear (pinna)25. The frequency characteristics of the sound waves are slightlymodified by the resonant characteristics of the external auditory canal20. These sound waves impinge upon the tympanic membrane (eardrum) 30,interposed at the terminus of the external auditory canal, between itand the tympanic cavity (middle ear) 35. Variations in the sound wavesproduce tympanic vibrations. The mechanical energy of the tympanicvibrations is communicated to the inner ear, comprising cochlea 60,vestibule 61, and semicircular canals 62, by a sequence of articulatingbones located in the middle ear 35. This sequence of articulating bonesis referred to generally as the ossicular chain 37. Thus, the ossicularchain transforms acoustic energy at the eardrum to mechanical energy atthe cochlea 60.

The ossicular chain 37 includes three primary components: a malleus 40,an incus 45, and a stapes 50. The malleus 40 includes manubrium and headportions. The manubrium of the malleus 40 attaches to the tympanicmembrane 30. The head of the malleus 40 articulates with one end of theincus 45. The incus 45 normally couples mechanical energy from thevibrating malleus 40 to the stapes 50. The stapes 50 includes acapitulum portion, comprising a head and a neck, connected to afootplate portion by means of a support crus comprising two crura. Thestapes 50 is disposed in and against a membrane-covered opening on thecochlea 60. This membrane-covered opening between the cochlea 60 andmiddle ear 35 is referred to as the oval window 55. Oval window 55 isconsidered part of cochlea 60 in this patent application. The incus 45articulates the capitulum of the stapes 50 to complete the mechanicaltransmission path.

Normally, prior to implantation of the hearing aid system according tosome embodiments of the invention, tympanic vibrations are mechanicallyconducted through the malleus 40, incus 45, and stapes 50, to the ovalwindow 55. Vibrations at the oval window 55 are conducted into the fluidfilled cochlea 60. These mechanical vibrations generate fluidic motion,thereby transmitting hydraulic energy within the cochlea 60. Pressuresgenerated in the cochlea 60 by fluidic motion are accommodated by asecond membrane-covered opening on the cochlea 60. This secondmembrane-covered opening between the cochlea 60 and middle ear 35 isreferred to as the round window 65. Round window 65 is considered partof cochlea 60 in this patent application. Receptor cells in the cochlea60 translate the fluidic motion into neural impulses which aretransmitted to the brain and perceived as sound. However, variousdisorders of the tympanic membrane 30, ossicular chain 37, and/orcochlea 60 can disrupt or impair normal hearing.

Hearing loss due to damage in the cochlea is referred to assensorineural hearing loss. Hearing loss due to an inability to conductmechanical vibrations through the middle ear is referred to asconductive hearing loss. Some patients have an ossicular chain 37lacking sufficient resiliency to transmit mechanical vibrations betweenthe tympanis membrane 30 and the oval window 55. As a result, fluidicmotion in the cochlea 60 is attenuated. Thus, receptor cells in thecochlea 60 do not receive adequate mechanical stimulation. Damagedelements of ossicular chain 37 may also interrupt transmission ofmechanical vibrations between the tympanic membrane 30 and the ovalwindow 55.

Implantable hearing aid systems have been developed, utilizing variousapproaches to compensate for hearing disorders. For example, cochlearimplant techniques implement an inner ear hearing aid system. Cochlearimplants electrically stimulate auditory nerve fibers within the cochlea60. A typical cochlear implant system may include an externalmicrophone, an external signal processor, and an external transmitter,as well as an implanted receiver and an implanted probe. A signalprocessor converts speech signals transduced by the microphone intoelectrical stimulation that is delivered to the cochlea 60.

A particularly interesting class of hearing aid systems includes thosewhich are configured for disposition principally within the middle earspace 35. In middle ear implantable (MEI) hearing aids, anelectrical-to-mechanical output transducer couples mechanical vibrationsto the ossicular chain 37, which is optionally interrupted to allowcoupling of the mechanical vibrations to the ossicular chain 37. Bothelectromagnetic and piezoelectric output transducers have been used toeffect the mechanical vibrations upon the ossicular chain 37.

One example of a partial middle ear implantable (P-MEI) hearing aidsystem having an electromagnetic output transducer comprises: anexternal microphone transducing sound into electrical signals; externalamplification and modulation circuitry; and an external radio frequency(RF) transmitter for transdermal RF communication of an electricalsignal. An implanted receiver detects and rectifies the transmittedsignal, driving an implanted coil in constant current mode. A resultingmagnetic field from the implanted drive coil vibrates an implantedmagnet that is permanently affixed only to the incus. Suchelectromagnetic output transducers have relatively high powerconsumption, which limits their usefulness in total middle earimplantable (T-MEI) hearing aid systems.

A piezoelectric output transducer is also capable of effectingmechanical vibrations to the ossicular chain 37. An example of such adevice is disclosed in U.S. Pat. No. 4,729,366, issued to D. W. Schaeferon Mar. 8, 1988. In the '366 patent, a mechanical-to-electricalpiezoelectric input transducer is associated with the malleus 40,transducing mechanical energy into an electrical signal, which isamplified and further processed. A resulting electrical signal isprovided to an electrical-to-mechanical piezoelectric output transducerthat generates a mechanical vibration coupled to an element of theossicular chain 37 or to the oval window 55 or round window 65. In the'366 patent, the ossicular chain 37 is interrupted by removal of theincus 45. Removal of the incus 45 prevents the mechanical vibrationsdelivered by the piezoelectric output transducer from mechanicallyfeeding back to the piezoelectric input transducer.

Piezoelectric output transducers have several advantages overelectromagnetic output transducers. The smaller size or volume of thepiezoelectric output transducer advantageously eases implantation intothe middle ear 35. The lower power consumption of the piezoelectricoutput transducer is particularly attractive for T-MEI hearing aidsystems, which may include a limited longevity implanted battery as apower source.

A piezoelectric output transducer is typically implemented as a ceramicpiezoelectric bi-element transducer, which is a cantilevered doubleplate ceramic element in which two opposing plates are bonded togethersuch that they amplify a piezoelectric action in a direction normal tothe bonding plane. Such a bi-element transducer vibrates according to apotential difference applied between the two bonded plates. A proximalend of such a bi-element transducer is typically cantilevered from atransducer mount which is secured to a temporal bone within the middleear. A distal end of such a bi-element transducer couples mechanicalvibrations to an ossicular element such as stapes 50.

FIG. 2 is a generalized illustration of a bi-element transducer 70cantilevered at its proximal end from a mount 75 secured to a temporalbone within middle ear 35. A distal end of bi-element transducer 70 ismechanically coupled to an auditory element to receive or effectmechanical vibrations when operating as an input or output transducerrespectively. For example, to receive mechanical vibrations as an inputtransducer, bi-element transducer 70 may be coupled to an auditoryelement such as a tympanic membrane 30 (shown in FIG. 1), malleus 40, orincus 45. In another example, to effect vibrations as an outputtransducer, bi-element transducer 70 may be coupled to an auditoryelement such as incus 45, stapes 50, oval window 55, round window 65,vestibule 61 (shown in FIG. 1), or semicircular canal 62. The transducer70 is coupled by leads 85 and 90 to an electronics unit 95.

FIG. 3 illustrates generally a cross-sectional view of anelectromechanical output transducer. A piezoelectric element, moreparticularly bi-element transducer 70, is mechanically coupled, andpreferably secured, at its proximal end to middle ear 35 (shown inFIG. 1) through an auditory element, preferably stapes 50, oralternatively incus 45, stapes 50, oval window 55, round window 65,vestibule 61, or semicircular canals 62. Bi-element transducer 70 can besecured only to stapes 50 by any known attachment technique, includingbiocompatible adhesives or mechanical fasteners. For example, in oneembodiment, a deformable wire (not shown) secured to the proximal end ofbi-element transducer 70 is looped through an inner portion of stapes50, for example, and crimped to secure bi-element transducer 70 tostapes 50.

Electronics unit 95 may couple an electrical signal through lead wires85 and 90 to any convenient respective connection points on respectiveopposing elements of bi-element transducer 70.

In response to the electrical signals received from electronics unit 95,bi-element transducer 70 bends with respect to a longitudinal planebetween its opposing elements. The bending is resisted by inertial mass80 which may be connected to bone through the use of adhesive or bonecement or a mechanical connector, for example a screw, thus mechanicallycoupling a force to stapes 50 through bi-element transducer 70. Thisforce upon stapes 50 is in turn transmitted to cochlea 60 at oval window55.

FIG. 4 illustrates generally a cross-sectional view of anelectromechanical input transducer. A piezoelectric element, such asbi-element transducer 70, is secured by any known attachment techniqueat its proximal end, such as described above, for example, to malleus40.

Bi-element transducer 70 may also be secured only to other auditoryelements for receiving mechanical vibrations, such as incus 45 ortympanic membrane 30. Vibrations of malleus 40 cause, at the proximalend of bi-element transducer 70, vibratory displacements that areopposed by inertial mass 80 which may be connected to bone through theuse of adhesive or bone cement or a mechanical connector, for example ascrew. As a result, bi-element transducer 70 bends with respect to thelongitudinal plane between its opposing elements. A resulting electricalsignal is provided at any convenient connection point on respectiveopposing elements of bi-element transducer 70, through respective leadwires 92 and 93 to electronics unit 95.

The ossicular chain can be severed at some part to break the normalsound conduction path from the ear drum (tympanic cavity), through themalleus handle through the malleus lateral process to the malleus head,then to the incus, to the incus lenticular process, to the limbs of thestapes, to the base of the stapes and to the oval (vestibular) window.In practice, the connection between the malleus and incus, or incus andstapes, can be severed, with the vibration sensor attached to the moreouter portion of the severed connection and the vibrator/transducerattached to the portion of the severed connection closer to the ovalwindow.

In previous devices, the sensor is a piezoelectric sensor and thevibrator is also a piezoelectric device. The sensor signal carries thesensed vibrations as electrical signals to the implanted medical devicewhich can amplify the signal and the amplified electrical signal carriedto the vibrator to drive the stapes or other bone to vibrate the ovalwindow.

The proximal ends and the heads of the sensor and the transducer canboth be located within a pocket carved out from the mastoid bone of theskull located behind the ear. In some current methods, both the sensorand the driver are cemented in place after securing the distal ends ofthe devices to the appropriate bones.

In many embodiments of the present invention, the implanted electronicdevice is disposed within a pocket formed in the skull by removing aportion of the skull after lifting the flap of skin. A sensor lead mayextend through a channel formed along the outside of the skull andcontinuing to the sensor device head which continues by extending intothe middle ear (tympanic) cavity. The sensor can sense the vibrations ofthe moving middle ear bone and transmit the vibrations as an electricalor optical signal to the implanted medical device. After processing andamplification, the transducer, driver, or vibrator lead can extendthrough a channel formed in the outside of the skull and be coupled tothe head of the vibrator which is coupled to the vibrator body which isin turn coupled to the stapes (for example).

In various embodiments of the present invention, the sensor lead may bereplaced by a different sensor lead and the driver or vibrator lead canbe replaced by a different lead as well. The sensor and vibrator bodiesmay also be replaced with different devices. In some embodiments, thesensor and/or vibrator bodies may still be secured at the proximalregion to the skull, but the exact location of the affixed bodiesrelative to the coupled bones may not be as critical as is currently thecase.

Conceptually, an accelerometer can behave as a damped mass on a spring.When the accelerometer experiences an acceleration, the mass isdisplaced to the point that the spring is able to accelerate the mass atthe same rate as the casing. The displacement can then be measured togive the acceleration.

In commercial devices, piezoelectric, piezoresistive and capacitivecomponents are commonly used to convert the mechanical motion into anelectrical signal. Piezoelectric accelerometers rely on piezoceramics(e.g. lead zirconate titanate) or single crystals (e.g. quartz,tourmaline) They are unmatched in terms of their upper frequency range,low packaged weight and high temperature range. Piezoresistiveaccelerometers are preferred in high shock applications. Capacitiveaccelerometers typically use a silicon micromachined sensing element.Their performance is superior in the low frequency range and they can beoperated in servo mode to achieve high stability and linearity.

Modern accelerometers are often small micro electromechanical systems(MEMS), and are indeed the simplest MEMS devices possible, consisting oflittle more than a cantilever beam with a proof mass (also known as aseismic mass). Damping results from the residual gas sealed in thedevice. As long as the Q-factor is not too low, damping does not resultin a lower sensitivity.

Under the influence of external accelerations the proof mass deflectsfrom its neutral position. This deflection is measured in an analog ordigital manner. Most commonly, the capacitance between a set of fixedbeams and a set of beams attached to the proof mass is measured. Thismethod is simple, reliable, and inexpensive. Integrating piezoresistorsin the springs to detect spring deformation, and thus deflection, is agood alternative, although a few more process steps are needed duringthe fabrication sequence. For very high sensitivities quantum tunnelinghas been used; this requires a dedicated process making it veryexpensive. Optical measurement has been demonstrated on laboratoryscale.

A far less common type of MEMS-based accelerometer contains a smallheater at the bottom of a very small dome that heats the air inside thedome to cause it to rise. A thermocouple on the dome determines wherethe heated air reaches the dome and the deflection off the center is ameasure of the acceleration applied to the sensor.

Most micromechanical accelerometers operate in-plane, that is, they aredesigned to be sensitive only to a direction in the plane of the die. Byintegrating two devices perpendicularly on a single die a two-axisaccelerometer can be made. By adding an additional out-of-plane devicethree axes can be measured. Such a combination may have much lowermisalignment error than three discrete models combined after packaging.

Micromechanical accelerometers are available in a wide variety ofmeasuring ranges, reaching up to thousands of g's. The designer mustoften make a compromise between sensitivity and the maximum accelerationthat can be measured.

Various accelerometers can include various technologies such aspiezoelectric accelerometers, shear mode accelerometers, surfacemicromachined capacitive (MEMS), thermal (submicron CMOS process), bulkmicromachined capacitive, bulk micromachined piezoresistive, capacitivespring mass base electromechanical servo (servo force balance),null-balance, strain gauge, resonance, magnetic induction, optical,surface acoustic wave (SAW), laser accelerometer, DC response, hightemperature, low frequency, high gravity, triaxial, modally tuned impacthammers, seat pad accelerometers, and pendulous integrating gyroscopicaccelerometer.

Accelerometers can include capacitive metal beam or micromachineddevices which produce change in capacitance related to acceleration;piezoelectric crystal mounted to mass having a voltage output convertedto acceleration; piezoresistive having a beam or micromachined featurewhose resistance changes with acceleration; a Hall Effect motion deviceproducing an electrical signal by sensing of changing magnetic fields; amagnetoresistive device having material resistivity changes in thepresence of a magnetic field.

The degree of vibration can be used also to determine whether thevibratory body is effectively coupled to the middle bone at the time ofthe initial surgery. This can be done as the vibratory behavior of thevibratory body will be different if the body is freely vibrating asopposed to being coupled to and driving the middle ear bone.

At a time long after the initial surgical implantation the vibratorybehavior of the bimorph can be compared with the initial behavior. Onechange could be the decoupling of the driven bimorph from the middle earbone. Another change could be added vibratory impedance or impediment tovibration. This impediment could be scar tissue, fluid, disease,unwanted growths, and the like. Significant changes could be signaled tothe patient and/or to medical professionals.

FIG. 5 illustrates one embodiment of the invention having a hermeticallysealed elongate housing or vibratory body 102 having an accelerometer100 included in the distal tip. The distal tip is secured to a bone ofthe middle ear, in this case, stapes 50. A proximal end 112 of body 102is shown, which can be used to anchor body 102 to a body region near themiddle ear, for example, part of the skull. In this example, body 102has a bi-element piezoelectric transducer to impart vibrations to thestapes. Bi-element 104 includes a first piezoelectric body 106, a secondpiezoelectric body 110, and a metallic center vane 108 disposed betweenbodies 106 and 110.

Three wires are shown extending from the proximal end 112 to theelectronics unit 118. In this example, wire 114 is used to drive thepiezoelectric transducer 104 and wire 115 is used to return sensor datafrom accelerometer 100. Wire 116 serves as a common ground, shared bypiezo electric transducer 104 and accelerometer 100. In anotherembodiment, the transducer 104 and the accelerometer 100 could each havea separate ground wire 116.

In some embodiments, the accelerometer is self powered, not requiringany externally wired power source. One example of this is apiezoelectric accelerometer, which generates its own electricalpotential or charge as it moves. The charge generated can then becoupled directly or indirectly to the electronics unit 118. In oneexample, the electrical potential is converted to light and transmittedto the electronics unit 118 via a fiber optic conduit.

FIG. 6 illustrates another embodiment of the invention having vibratorybody 126 with a distal region 124 and a distal tip 125 coupled to astapes 50 using adhesive or cement 120. An accelerometer 122 is disposedin the vibratory body 126 in the distal region 124 distant from thedistal tip 125. The acceleration measured may be different than theacceleration at the distal tip. The acceleration at the distal tip canbe calculated using the known geometry of the vibratory body, inparticular the distance of accelerometer 122 from the distal tip.

Some accelerometers, for example capacitive accelerometers, are notself-powered and require an externally wired power source. In thisexample, four wires couple elongate body proximal end 127 to anelectronics unit 136. Wire 130 can be used to drive bi-element 128 whilewire 132 can be used to power accelerometer 122. Wire 134 can be used toreturn acceleration data from accelerometer 122 and wire 135 can serveas a common ground. In another embodiment, the bi-element 128 and theaccelerometer 122 could each have a separate ground wire 135.

The accelerometer data obtained can be used as an indication of actualacceleration of the vibratory body. Velocity is the rate of change ofposition of an object, the first derivative of the position.Acceleration is the rate of change of the velocity, the secondderivative of the position. Acceleration can be integrated to obtain thevelocity and velocity can be integrated to determine the displacement oractual motion of the accelerometer. For these reasons, the accelerationwaveform can be used itself as an indication of the motion of the middleear element such as an incus, stapes, or a transducer. Therefore, achange in acceleration at the same frequency over time is indicative ofchanges in the implanted system, for example, decoupling of thevibratory body from the middle bone, fluid accumulation, scar tissue,and the like.

What is claimed is:
 1. An implantable vibrational device for vibratingan ossicle bone of the middle ear, the device comprising: an elongatemember having a first end region adapted to fixedly secure to a skulltemporal bone in the middle ear and a second end region configured forcoupling to a middle ear ossicle bone; a driven vibrating elementcoupled to the elongate member; an accelerometer secured to the elongatemember second end region; and a signal communication element forcommunicating information to a location outside of the elongate memberwhere the signal communication element is coupled to the accelerometer.2. The device of claim 1 in which the signal communication elementincludes an electrical conductor.
 3. The device of claim 2 in which theelectrical conductor extends from the first end region.
 4. The device ofclaim 1 in which the signal communication element includes an opticalsignal conductor.
 5. The device of claim 4 in which the opticalconductor extends from the first end region.
 6. The device of claim 1 inwhich the accelerometer is selected from the group consisting ofself-powered sensors, piezo electric sensors, externally poweredsensors, and capacitive sensors and/or combinations thereof.
 7. Thedevice of claim 1, further comprising an implantable electronic devicecoupled to receive information from the accelerometer.
 8. The device ofclaim 7 in which the implantable electronic device includes embeddedexecutable logic and/or computer code for detecting excessively impededvibration of the elongate member.
 9. The device of claim 7 in which theimplantable electronic device includes embedded executable logic and/orcomputer code for detecting undesirably un-impeded vibration of theelongate member.